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ABSORB (Amount of Blueberries So Older Adults Reap Benefits)

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Hebrew SeniorLife

Status

Completed

Conditions

Aging
Depressive Symptoms

Treatments

Other: Freeze-dried Blueberry Powder

Study type

Interventional

Funder types

Other

Identifiers

NCT05937165
Pro00069826

Details and patient eligibility

About

This randomized, cross-over, pilot study aims to compare preliminary impact of a standard dose of blueberry powder (24 g) vs a higher dose (48 g) on the bioavailability of flavonoids and inflammatory biomarkers in older adults with minor levels of depressive symptoms.

Full description

Blueberries are a rich source of anti-oxidants and dietary fiber, and are recommended to consume as a part of a healthy diet. Regular consumption of blueberries as a source of dietary antioxidants may be an effective way to lower inflammation in older adults, who commonly have higher levels of inflammatory markers. However, older adults typically have a decreased efficiency of nutrient absorption and may need a higher dose of blueberries to absorb enough of the flavonoids needed to reap their benefits on inflammation. Thus, it is important for preliminary studies to pre-determine an appropriate dose of blueberry flavonoids specifically for older adults. This study aims to evaluated the preliminary impact of freeze-dried blueberry powder consumption on flavonoid bioavailability and inflammatory biomarkers in older adults. This will be an individual-level, unblinded, randomized, cross over pilot study in 5 older adults with minor levels of depressive symptoms. Eligible participants will collect a 24 hour urine sample, and then come in for the baseline assessments and provide a blood sample. Next they will be randomized to consume either the higher dose (48 g/day, equivalent ~ 2 cups of fresh blueberries) or the lower dose (24 g/day, equivalent ~1 cup of fresh blueberries) for 3 days. After 3 days they will begin collecting a 24 hour urine sample, and come in to repeat the baseline assessments and provide a blood sample. After a two week wash out period, participants will repeat the same baseline and follow-up assessments while consuming the other powder.

Enrollment

6 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Men and women aged 65 years and older
  • Minor levels of depressive symptoms (center for epidemiological studies depression scale, ≥4 and <16 points)

Exclusion Criteria*:

  • Unwilling to follow the study protocol

  • Cognitive impairment (assessed via the telephone Montreal Cognitive Assessment) defined as individuals scoring <19)

  • Self-reporting a history of major depression, bipolar, schizophrenia, or other psychotic or neurologic disorders

  • Self-reporting of history gastro-intestinal diseases/conditions e.g., of bowel resection, inflammatory bowel disease/syndrome, Celiac disease

  • Self-reporting immune disorders, e.g., rheumatoid arthritis, cancer, and other immunocompromising conditions

  • Self-reporting history of type 1 or type 2 diabetes

  • Self-reporting any history of substance or alcohol use disorder

  • Allergy to blueberries

  • Self-reporting use of anti-inflammatory (e.g., fish oil or non-steroidal anti-inflammatory drugs) or immune-suppressant drugs

  • Are excessive tea or coffee consumers (e.g., >3 cups/day)

  • Recent and consistent use of antibiotics

  • Currently taking or advised during the intervention to take anti-depressants

  • Current homicidal or suicidal ideation (assessed via the P4 Suicidality Screener

    • All deviations must be approved by the study sponsor

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

6 participants in 2 patient groups

Standard Dose Freeze-dried Blueberry Powder
Active Comparator group
Description:
Consumption of 24 g of freeze dried blueberry powder for 3 consecutive days.
Treatment:
Other: Freeze-dried Blueberry Powder
Higher Dose Freeze-dried Blueberry Powder
Experimental group
Description:
Consumption of 48 g of freeze dried blueberry powder for 3 consecutive days.
Treatment:
Other: Freeze-dried Blueberry Powder

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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